Reported May 13, 2020 · Terminated

HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use…

Maquet Cardiovascular, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet Cardiovascular, LLC · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch
  • Product CodeM00202175824P0 -
  • Product Usagefor use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
Lot codes and dates
  • Serial Numbers

    65 of 65 codes

    • 1069833603
    • 1069800979
    • 1069830915
    • 1069822813
    • 1069826494
    • 1073232852
    • 1073244538
    • 1073248356
    • 1073247694
    • 1073238111
    • 1073244655
    • 1073245805
    • 1074078868
    • 1074096981
    • 1073245180
    • 1075816095
    • 1075833820
    • 1075817616
    • 1075822171
    • 1121372880
    • 1121440106
    • 1121438219
    • 1121372041
    • 1121396486
    • 1121390993
    • 1121413834
    • 1121410287
    • 1123883969
    • 1123881709
    • 1123882605
    • 1126691350
    • 1131379994
    • 1150412103
    • 1150432593
    • 1150316987
    • 1150489896
    • 1150511448
    • 1150483701
    • 1162227315
    • 1162227920
    • 1162231345
    • 1177013851
    • 1176957069
    • 1177022361
    • 1177037106
    • 1177062054
    • 1180553781
    • 1180752802
    • 1184425670
    • 1073247948
    • 1073255445
    • 1075827022
    • 1080534907
    • 1120128533
    • 1120067440
    • 1121368128
    • 1121428442
    • 1121415860
    • 1123880071
    • 1150432730
Amount recalled
N/A

This recall covers 24 products

The agency filed one notice per product. You are reading one of them; the other 23 are below.

11 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 5, 2021 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.